What is the difference between KRIs, KPIs, and KQIs in Risk-based Monitoring? Explained simply.

What is the difference between KRIs, KPIs, and KQIs in Risk-based Monitoring? Explained simply.

Anyone familiar with Risk-based Monitoring (RbM), will at some point have come in contact with such terms as Key Risk Indicators (KRIs), Key Performance Indicators (KPIs) and even Key Quality Indicators(KQI).

I’m sure most people are aware that there are differences between these indicators, but these differences are not always obvious. Let me try to clarify.

For the sake of simplicity, let’s take an example: Imagine you’re sitting in your car and you’re looking at the dashboard. In front of you are some KRIs and KPIs.

Car dashboard contains a number of KRIs and KPIs

For instance, a speedometer is a simple performance indicator, it tells you how fast you are driving. It does not tell you if you should drive 50 km/h or 80 km/h in a particular area, this information should already be known to the driver.

A risk indicator is a slightly more complicated construct. In our example, it would be a fuel gauge. It consists of a performance indicator: the number of liters in the tank and additional thresholds, which warn a driver (in two stages) to top up the tank soon. If she/he does not take any action, a complication (or ‘risk’) will occur, in this case, the car will run out of fuel and will break down.

Thus, this would mean a performance indicator contains only measurement of one metric, and a KRI incorporates additional information about thresholds and certain risk, which may happen if no further action is undertaken.

Typical KPIs within RbM are:

Number of enrolled patients

Number of adverse events (AEs) per site

Number of patient weeks (i.e. how many weeks patients are in a clinical trial)

Now, if we add additional thresholds, or rather, information from experience, we can covert the KPIs into KRIs:

Number of enrolled patients is less than it was planned

Number of AEs is too high per site comparing to other sites in the same clinical trial

Average number of patient weeks per month is decreasing, e.g. due to high drop-out rates

Above on the picture, you can see a number of joined KQIs. E.g., Vital signs score applies several sanity checks on vital signs such as body temperature, pulse rate, blood pressure.

Another well-known data quality indicator, which is applicable for the whole trial, is “confidence intervals” of the measured data. A threshold used in this context – “statistical significance”, the p-value, which in clinical trials must be less than 5%. Different significance levels (e.g., 1%) may be applied depending on the field of study[1].

Another typical KQI in RbM would be “normality test”, which indicates whether data is normally distributed or skewed. The skewed data is often influenced by a systematic error, which shifts the bell-shaped distribution to one side or another (see below).

The advantage of KPIs, and KQIs is their comparability among trials and retrospectively. The KRIs are more useful for their predictability of the dangerous situations as taking the right actions at the right time can prevent unwanted consequences.

CAPA on practice

Summing up, all discussed instruments like KPIs, KRIs, KQIs in RbM aim at identifying, assessing, controlling, communicating and reviewing risks associated with your clinical trial during its lifecycle. This will facilitate making your trial safer for the patients, giving your trial management team full control over a trial and helping to flag any dangerous situations before they occur.

Share This Story!

Professional in the integration of data-driven Risk-based Monitoring (RbM) process in international clinical trials of pharmacology.
Speaker at regional and global conferences such as: DIA, PharmaForum, PharmaDay, DGGF, etc.
10+ years of experience in data quality projects and biostatistics for the pharmaceutical industry.
Life passion: improving clinical research with RbM, driving the RbM research to new frontiers for CROs, pharma and biotech companies.

4 Comments

Uri
February 20, 2015 at 3:51 am

This kind of process could be use in a research
site

Artem Andrianov
February 26, 2015 at 4:18 pm

Do you mean the application of KRIs, KPIs, KQI for measurement?
Sure, I even hope that it is used in a research site as a part of holistic RbM process. Today the sites are usually not involved into the RbM process and cannot control their quality and performance.
In the trials, which are built with our RbM system(See EarlyBird) we are including Sites into the whole process and let them monitor their KRIs, KPIs, KQI regular and even compare with other sites.